BLOOD CONTAINMENT PACK

General Surgery Tray

PROFESSIONAL MEDICAL SERVICES

The following data is part of a premarket notification filed by Professional Medical Services with the FDA for Blood Containment Pack.

Pre-market Notification Details

Device IDK872448
510k NumberK872448
Device Name:BLOOD CONTAINMENT PACK
ClassificationGeneral Surgery Tray
Applicant PROFESSIONAL MEDICAL SERVICES P.O. BOX 250 700 WEST 200 NORTH North Salt Lake,  UT  84054
ContactJames E Williams
CorrespondentJames E Williams
PROFESSIONAL MEDICAL SERVICES P.O. BOX 250 700 WEST 200 NORTH North Salt Lake,  UT  84054
Product CodeLRO  
CFR Regulation Number878.4370 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-06-23
Decision Date1987-11-17

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